DRKIDS CHILDRENS COUGH AND CHEST CONGESTION DM- dextromethorphan hydrobromide, guaifenesin solution 
CalmCo LLC

----------

DrKids Children’s Cough & Chest Congestion DM

Active Ingredient (in each 5mL)

Dextromethorphan HBr, USP, 5mg

Guaifenesin, USP, 100mg

Purpose

Cough suppressant

Expectorant

Uses

Warnings

Do not use

if your child is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for two weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if your child has

persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if

cough lasts for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

do not give more than 6 doses in any 24 hour period
give the recommended number of vials below, following the instructions under How to Open and Use on the side panel
empty all liquid in each Single-Use Vial when dosing

Dosing Chart

Age (Years) Dose
under 4 yearsConsult a doctor
4 – 5 years 1 Single-Use Vial (5 mL) every 4 hours
6 – 11 years 1 – 2 Single-Use Vials (5 mL each) every 4 hours
Adults and children 12 years and over 2 – 4 Single-Use Vials (5 mL each) every 4 hours



Inactive Ingredients

citric acid, glycerin, mixed berry flavor, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum

Other information

Questions or comments?

941-202-3270 or visit www.DrKids.com

Package

PDP

DRKIDS CHILDRENS COUGH AND CHEST CONGESTION DM 
dextromethorphan hydrobromide, guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73282-0013
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SORBITOL (UNII: 506T60A25R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73282-0013-120 in 1 CARTON12/15/2023
15 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01212/15/202310/31/2025
Labeler - CalmCo LLC (079308308)

Revised: 5/2024
Document Id: 1934fe44-8c2d-a796-e063-6294a90a52f9
Set id: c8d73754-5efe-6bd4-e053-2a95a90a3d2f
Version: 5
Effective Time: 20240524
 
CalmCo LLC